DTC Working Groups (WGs) address issues of regulation and standards for finished drug products.
The RFID WG is looking at implications of using radio-frequency identification devices on boxes containing pharmaceutical products.
The Container/Closure Systems WG is developing test methods and evaluation criteria in support of FDA's PACPAC guidance.
The Excipients WG is developing current practices for control of excipients and will explore ways for more efficient controls.
The Aerodynamic Particle Size Distribution Mass Balance WG is evaluating the suitability of specifications for mass balance obtained from cascade impactor measurements, as recommended in draft FDA guidances for orally inhaled and intranasal drug products.
The Aerodynamic Particle Size Distribution Profile Comparisons WG is developing a robust statistical method (and evaluating that proposed in a draft FDA guidance) for establishing in vitro bioequivalence of aerosol particle size distributions of orally inhaled and intranasal drug products.
The Leachables and Extractables WG is developing reporting and qualification thresholds for leachables in orally inhaled and intranasal drug products.
The Impurities WG is determining appropriate methods and extent of characterization for impurities as a function of the stage of product development.
The Physical Attributes/ Particle Size WG is discussing test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.
The Specifications/ BACPAC WG is considering a core set of specifications (test, analytical methods, and acceptance criteria) that would assure the identity, strength, quality, purity and potency of a drug substance following a manufacturing change after the final intermediate.
